Contrast Ultrasound in the Surveillance of Endovascular Abdominal Aortic Aneurysm Repair

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

140 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-09-30

Study Completion Date

2012-03-31

Brief Summary

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The purpose of this study is to support the suspected expectation that Contrast enhanced Ultrasound (CUS) detects all endoleaks that have been detected by Computed Tomography (CT), and also find a number of leaks missed by CT.

The investigators' primary goal is to detect no difference between CT and CUS and provide evidence that CUS is a possible alternative to CT.

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Detailed Description

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Conditions

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Endovascular Abdominal Aortic Aneurysm Repair

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Phase 1 - Pilot phase

Total of 10 patients currently undergoing EVAR Surveillance. These 10 patients include 5 patients with endoleak known from a recent CT scan and 5 patients with no endoleak and shrinking aneurysm.

No interventions assigned to this group

Phase 2 - Blinded from CT Scan

This phase of study involves recruitment of 150 patients currently under post-EVAR surveillance. The physicians and ultrasound technologists will be blinded to the result of the CT Scan when performing and interpreting the CUS. The current schedule for EVAR Surveillance will be maintained so that an individual may receive more than one enhanced CT Scan and CUS during the 18 months of the study.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* All patients who underwent EVAR at The Ottawa Hospital and currently under post-EVAR surveillance at The Ottawa Hospital.

Exclusion Criteria

* Unable to consent for injection of contrast
* Unable to acquire IV access
* Right-to-left, bi-directional, or transient right-to-left cardiac shunts
* Severe pulmonary disease
* Previous hypersensitivity to DEFINITY® or its components
* Unable to be followed as a outpatient by the Vascular Diagnostic Center

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes